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Evaluation of safety and Efficacy of Chymoral Forte in wound healing potential after orthopaedic surgery.

Phase 4
Completed
Conditions
Health Condition 1: null- Post orthopaedic surgery patient
Registration Number
CTRI/2011/07/001920
Lead Sponsor
Elder Pharmaceuticals Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
75
Inclusion Criteria

1.Patient of either sex between 18 to 60 years of age

2.Patient to undergo elective clean and uncontaminated surgery for open reduction of fracture

3.Patients willing to take the medications as directed

4.Willing to comply with the protocol requirements

5.Willing to give the written informed consent

Exclusion Criteria

1.Patients with known hypersensitivity to any of the study related drugs (i.e. trypsin-chymotrypsin , serratiopeptidase , Bromelain & Rutoside)

2.Patients undergoing emergency surgery & those with contaminated surgery

3.Patients with known hepatic or renal impairment

4.Patients not willing to give written informed consent

5.Uncontrolled diabetes mellitus or any other metabolic disorder.

6.Pediatric and Pregnant patients.

7.Treatment with any investigational drug in the preceding 4 weeks.

8.Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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